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Safety and Efficacy of SHPL-49 Injection in Participants With Acute Ischemic Stroke

NCT06202378 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 270

Last updated 2025-10-28

No results posted yet for this study

Summary

This study is designed to determine the safety and efficacy of SHPL-49 intravenous infusion for 7 consecutive days in the treatment of acute ischemic stroke subjects.

Conditions

  • Acute Ischemic Stroke

Interventions

DRUG

3 ampoules of SHPL-49 Injection

3 ampoules of SHPL-49 Injection in 100 mL 0.9% sodium chloride will be administered as a 30-minute intravenous infusion and applied twice daily for 7 days.

DRUG

6 ampoules of SHPL-49 Injection

6 ampoules of SHPL-49 Injection in 100 mL 0.9% sodium chloride will be administered as a 30-minute intravenous infusion and applied twice daily for 7 days.

DRUG

0.9% Sodium Chloride Injection

100 mL 0.9% sodium chloride will be administered as a 30-minute intravenous infusion and applied twice daily for 7 days.

Sponsors & Collaborators

  • Beijing Tiantan Hospital

    collaborator OTHER

  • Shanghai Hutchison Pharmaceuticals Limited

    lead INDUSTRY

Principal Investigators

  • Yongjun Wang, master · Beijing Tiantan Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-29
Primary Completion
2024-11-26
Completion
2024-12-16
FDA Drug
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06202378 on ClinicalTrials.gov